Critical Illness Clinical Trial
— Leuven-GIDOfficial title:
Neurocognitive Development in Children With Congenital Heart Disease: Growing Into Deficit
Verified date | January 2016 |
Source | Katholieke Universiteit Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | Belgium: Institutional Review Board |
Study type | Observational |
The key objective of the Leuven growing-into-deficit (GID) follow-up-study is to test the hypothesis that children with a congenital heart disease (CHD) show more neurocognitive impairment at the second follow-up at 7 years old than at the first follow-up at the age of 4, compared to healthy controls.
Status | Completed |
Enrollment | 172 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 84 Months to 89 Months |
Eligibility |
Inclusion Criteria: - Seven-year-old children with CHD and healthy control children who were four years old when they participated in Paediatric ICU follow-up study (i.e. first follow-up time point) (Neurocognitive development of children four years after critical illness and treatment with tight glucose control, Clinical Trials # NCT00214916). The children of the CHD-group underwent cardiac surgery as infants (=<1year). Exclusion Criteria: - Genetic syndromes (Down, 22q11del), known to result in neurocognitive impairment - IQ < 70 - Lack of baseline neurocognitive measurements during first follow-up - Date of birth before February 2005 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Belgium | Dept Intensive Care Medicine | Leuven | Vlaams Brabant |
Lead Sponsor | Collaborator |
---|---|
Katholieke Universiteit Leuven |
Belgium,
Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | reaction time (RT) and error rates of inhibitory control (Response Organization Objects, ROO) (Amsterdam Neuropsychological Tasks, ANT) | one testpoint at age of 7 years | No | |
Secondary | reaction time (RT) and error rates of cognitive flexibility (ROO, ANT) and working memory (Memory Search - Objects 2 Keys, ANT) | one testpoint at age of 7 years | No | |
Secondary | Mean RT + standard deviation (SD) of RT on computerized alertness task (Baseline Speed, ANT) | one testpoint at age of 7 years | No | |
Secondary | Number of taps on computerized tapping tasks (ANT) | one testpoint at age of 7 years | No | |
Secondary | IQ measures (Revised Wechsler Preschool and Primary Scale of Intelligence, WPPSI-R) | one testpoint at age of 7 years | No | |
Secondary | Visual-Motor Integration total standard score (VMI) | one testpoint at age of 7 years | No | |
Secondary | Child Behavior CheckList T-scores for internalizing and externalizing problems | one testpoint at age of 7 years | No | |
Secondary | Pediatric Quality of Life Inventory - Generic Score Scales (PedsQL) to quantify quality of life | one testpoint at age of 7 years | No | |
Secondary | Behavior Rating Inventory of Executive Function (BRIEF) to measure executive functions (parent and teacher version) | one testpoint at age of 7 years | No | |
Secondary | Teacher Report Form (TRF) T-scores for internalizing and externalizing problems at school | one testpoint at age of 7 years | No | |
Secondary | Incidence of medical problems (e.g. head trauma), interventions and operations since first follow-up | one testpoint at age of 7 years | No |
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